OCCObaby

GUDID 00863101000313

The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.

DEOCCO LLC

Infrared patient thermometer, skin

• Primary Device ID: 00863101000313
• NIH Device Record Key: a0b5a881-3669-4b88-9f23-7efa009bea47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCCObaby
• Version Model Number: OCCOscan
• Company DUNS: 080378236
• Company Name: DEOCCO LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863101000313 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131243

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [OCCObaby]

• 00863101000320: Bundle of two thermometers: OCCOscan - The Non-contact Infrared Thermometer uses infrared sensor
• 00863101000313: The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated in
• 00863101000306: Digital Thermometer enables fast and reliable measurements. These thermometers provide very high
• 00850016971104: Digital Thermometer enables fast and reliable measurements. These thermometers provide very high